TriangleNCT01897714 · OUTCOME
Percentage of Patients Who Achieved Best Overall Disease Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline (Cycle 1 Day 1) and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.
What was measured
The best overall disease response on treatment including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD) or progressive disease (PD) were evaluated. Starting on completion of Cycle 2, response was assessed according to International Myeloma Working Group (IMWG) criteria based on Investigator's assessment for all patients at every cycle during treatment period. PD was defined as increase of ≥25% from lowest response value in any 1 of the following: serum M-component (absolute increase must be ≥0.5 gram/deciliter) and/or urine M-component (absolute increase must be ≥200 mg/24 hr); development of new bone lesions or soft tissue plasmacytomas or increase in size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that could be attributed solely to plasma cell proliferative disorder. SD was defined as not meeting criteria for CR, VGPR, PR or PD.
Analysis population: For Phase I arms: The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug. For Phase II arms: Modified Intent-to-Treat (mITT) Analysis Set included all patients considered to be valid for Safety Analysis Set and who received at least 1 dose of study drug at the MTD as initial dose.
Groups in this outcome
Phase I: Melflufen 15 mg + Dexamethasone
Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Phase I: Melflufen 25 mg + Dexamethasone
Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Phase I: Melflufen 40 mg + Dexamethasone
Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Phase I: Melflufen 55 mg + Dexamethasone
Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
Phase I + II: Melflufen 40 mg + Dexamethasone
Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
Phase II: Melflufen 40 mg (Single Agent)
Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
| Group | Source count |
|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 4 |
| Phase I: Melflufen 25 mg + Dexamethasone | 7 |
| Phase I: Melflufen 40 mg + Dexamethasone | 6 |
| Phase I: Melflufen 55 mg + Dexamethasone | 6 |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 45 |
| Phase II: Melflufen 40 mg (Single Agent) | 13 |
Reported measurements
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 7.9 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 0.0 | Not reported | 0.0 | 24.7 | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 7.9 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 0.0 | Not reported | 0.0 | 24.7 | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 11.1 | Not reported | 3.7 | 24.1 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 0.0 | Not reported | 0.0 | 24.7 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 50.0 | Not reported | 11.8 | 88.2 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 20.0 | Not reported | 9.6 | 34.6 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 7.7 | Not reported | 0.2 | 36.0 | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 17.8 | Not reported | 8.0 | 32.1 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 15.4 | Not reported | 1.9 | 45.4 | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 75.0 | Not reported | 19.4 | 99.4 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 42.9 | Not reported | 9.9 | 81.6 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 66.7 | Not reported | 22.3 | 95.7 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 26.7 | Not reported | 14.6 | 41.9 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 69.2 | Not reported | 38.6 | 90.9 | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 25.0 | Not reported | 0.6 | 80.6 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 57.1 | Not reported | 18.4 | 90.1 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 15.6 | Not reported | 6.5 | 29.5 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 7.7 | Not reported | 0.2 | 36.0 | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 8.9 | Not reported | 2.5 | 21.2 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 0.0 | Not reported | 0.0 | 24.7 | Not reported |
sCR + CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 7.9 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 0.0 | Not reported | 0.0 | 24.7 | Not reported |
sCR + CR + VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Melflufen 15 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Phase I: Melflufen 25 mg + Dexamethasone | 0.0 | Not reported | 0.0 | 41.0 | Not reported |
| Phase I: Melflufen 40 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I: Melflufen 55 mg + Dexamethasone | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I + II: Melflufen 40 mg + Dexamethasone | 11.1 | Not reported | 3.7 | 24.1 | Not reported |
| Phase II: Melflufen 40 mg (Single Agent) | 0.0 | Not reported | 0.0 | 24.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 7.9
- value
- 0.0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0.0
- title
- sCR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 7.9
- value
- 0.0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0.0
- title
- CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG004
- lower Limit
- 3.7
- upper Limit
- 24.1
- value
- 11.1
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0.0
- title
- VGPR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 11.8
- upper Limit
- 88.2
- value
- 50.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG004
- lower Limit
- 9.6
- upper Limit
- 34.6
- value
- 20.0
- group Id
- OG005
- lower Limit
- 0.2
- upper Limit
- 36.0
- value
- 7.7
- title
- PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG004
- lower Limit
- 8.0
- upper Limit
- 32.1
- value
- 17.8
- group Id
- OG005
- lower Limit
- 1.9
- upper Limit
- 45.4
- value
- 15.4
- title
- MR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75.0
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 81.6
- value
- 42.9
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG003
- lower Limit
- 22.3
- upper Limit
- 95.7
- value
- 66.7
- group Id
- OG004
- lower Limit
- 14.6
- upper Limit
- 41.9
- value
- 26.7
- group Id
- OG005
- lower Limit
- 38.6
- upper Limit
- 90.9
- value
- 69.2
- title
- SD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 80.6
- value
- 25.0
- group Id
- OG001
- lower Limit
- 18.4
- upper Limit
- 90.1
- value
- 57.1
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG004
- lower Limit
- 6.5
- upper Limit
- 29.5
- value
- 15.6
- group Id
- OG005
- lower Limit
- 0.2
- upper Limit
- 36.0
- value
- 7.7
- title
- PD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG004
- lower Limit
- 2.5
- upper Limit
- 21.2
- value
- 8.9
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0.0
- title
- Missing
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 7.9
- value
- 0.0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0.0
- title
- sCR + CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 41.0
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG004
- lower Limit
- 3.7
- upper Limit
- 24.1
- value
- 11.1
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0.0
- title
- sCR + CR + VGPR
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 45
- group Id
- OG005
- value
- 13
- units
- Participants
- description
- The best overall disease response on treatment including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD) or progressive disease (PD) were evaluated. Starting on completion of Cycle 2, response was assessed according to International Myeloma Working Group (IMWG) criteria based on Investigator's assessment for all patients at every cycle during treatment period. PD was defined as increase of ≥25% from lowest response value in any 1 of the following: serum M-component (absolute increase must be ≥0.5 gram/deciliter) and/or urine M-component (absolute increase must be ≥200 mg/24 hr); development of new bone lesions or soft tissue plasmacytomas or increase in size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that could be attributed solely to plasma cell proliferative disorder. SD was defined as not meeting criteria for CR, VGPR, PR or PD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
- id
- OG000
- title
- Phase I: Melflufen 15 mg + Dexamethasone
- description
- Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
- id
- OG001
- title
- Phase I: Melflufen 25 mg + Dexamethasone
- description
- Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
- id
- OG002
- title
- Phase I: Melflufen 40 mg + Dexamethasone
- description
- Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
- id
- OG003
- title
- Phase I: Melflufen 55 mg + Dexamethasone
- description
- Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
- id
- OG004
- title
- Phase I + II: Melflufen 40 mg + Dexamethasone
- description
- Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
- id
- OG005
- title
- Phase II: Melflufen 40 mg (Single Agent)
- param Type
- NUMBER
- population Description
- For Phase I arms: The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug. For Phase II arms: Modified Intent-to-Treat (mITT) Analysis Set included all patients considered to be valid for Safety Analysis Set and who received at least 1 dose of study drug at the MTD as initial dose.
- reporting Status
- POSTED
- time Frame
- Baseline (Cycle 1 Day 1) and every cycle from Cycle 2 onwards until confirmed disease progression. Assessed until EOT date of 29 October 2019; up to a maximum of approximately 76 months.
- title
- Percentage of Patients Who Achieved Best Overall Disease Response
- type
- PRIMARY
- unit Of Measure
- percentage of patients
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Preserved source evidence · Not medical advice